Welcome to the Office of Research Compliance

The Office of Research Compliance was created to develop, coordinate, communicate, plan, implement, and monitor compliance in human subjects research at Sunrise Health sites. The responsibilities and functions of this office include the following:

• Facilitate research compliance initiatives throughout Sunrise Health and Sunrise Health -related entities.
• Provide training of investigators, clinical coordinators, and other research-related staff concerning research-related statutory and regulatory requirements and Sunrise Health policies.
• Develop a mechanism to raise questions and to receive appropriate guidance concerning research-related statutory and regulatory requirements.
• Regularly review research activity through its Institutional Review Board to assess research compliance and to identify potential noncompliance.
• Develop and maintain a process to report instances of possible noncompliance and for such reports to be fully and independently reviewed.
• Develop a process for formulating and recommending corrective action plans to address any instances of noncompliance with Sunrise Health research-related policies and with federal and state laws and regulations related to research.
• Create and incorporate standards and policies to guide research activities.

The Office of Research Compliance has developed this web site to provide all researchers the guidance and information needed to maintain compliance in the area of human subjects research.

The Office of Research Compliance is the administrative unit of the Institutional Review Board.

The Institutional Review Board

All research projects involving human subjects, conducted at Sunrise Health institutions, must be approved by the Sunrise Health Institutional Review Board (SHIRB).

In accordance with the Department of Health and Human Services (DHHS), 45 CFR 46, and the regulations of the Food and Drug Administration, 21 CFR 50, the IRB has the authority to review, approve, require modifications in, or disapprove all human-subjects research activities that fall within its jurisdiction. The jurisdiction of the Sunrise Health IRB is defined by its Federal-wide Assurance document with the DHHS and by Sunrise Health institutional policies.

The Board of Trustees of Sunrise Health has designated the IRB as the compliance committee responsible for reviewing and approving human subjects research. No human subjects research activity may be conducted at any Sunrise Health institution unless the SHIRB has reviewed and approved the research prior to commencing the research activity.

This site will offer resources such as the IRB’s standard operating procedures manual, Federal-wide assurance information, IRB requirements and procedures, committee information, training requirements, application information, meeting schedules, and useful links for those involved in research. In coordination with the IRB, we hope to provide the best service we can to the research community at Sunrise Health institutions.

If you have any questions regarding the IRB, please contact the IRB Office at (702) 731-8559, or email sunrise.orc@hcahealthcare.com.